Work with Flori­da on its drug im­port pro­gram, Trump tells Azar — re­port

Drug im­por­ta­tion is com­ing to the Unit­ed States — well, Flori­da — and Pres­i­dent Trump is on for the ride.

A Politi­co re­port pub­lished on Mon­day, sug­gests that Trump has asked HHS sec­re­tary Alex Azar to work with Flori­da gov­er­nor Ron De­San­tis on the state’s drug im­port plan, cit­ing con­gress­man Matt Gaetz who at­tend­ed an Oval Of­fice meet­ing that last­ed for about 45 min­utes on Mon­day af­ter­noon, dur­ing which the is­sue was re­port­ed­ly dis­cussed.

Alex Azar

Flori­da’s pro­gram — which fa­cil­i­tates the im­por­ta­tion of drugs from Cana­da for the state’s health de­part­ments — is set to come in­to force on Ju­ly 1. It has been the sub­ject of fierce crit­i­cism from the drug lob­by and pres­i­dent Trump’s ad­vis­ers, in­clud­ing Azar.

At the meet­ing at the White House on Mon­day, Azar — for­mer pres­i­dent of Lil­ly’s US op­er­a­tions and BIO board mem­ber — aired his con­cerns about the pro­gram, sug­gest­ing that man­u­fac­tur­ers could lim­it pre­scrip­tion drug sup­plies if they don’t make enough mon­ey, and ques­tioned how to en­sure the safe­ty of im­port­ed med­i­cines, the re­port said.

Matt Gaetz

Ac­cord­ing to Gaetz, Trump said the drug im­ports would in­stead trig­ger drug com­pa­nies to low­er their US prices, and that the meet­ing had been called to fa­cil­i­tate the re­view of the pro­gram by Azar’s de­part­ment, with a view to sub­se­quent­ly ap­prove it.

“We’re like the Blues Broth­ers of drug im­por­ta­tion,” Gaetz, a De­San­tis ad­vis­er, told Politi­co on Mon­day. “We’re on a mis­sion from God.”

Rep­re­sen­ta­tives from PhRMA and BIO con­demned the pro­gram.

“No Sec­re­tary of the De­part­ment of Health and Hu­man Ser­vices has ever ap­proved a drug im­por­ta­tion pro­pos­al be­cause of the dif­fi­cul­ty of en­sur­ing that pa­tients would not be put in harm’s way and that it would al­so save pa­tients mon­ey. Any and all im­por­ta­tion schemes threat­en the safe­ty of pa­tients and are the wrong ap­proach for Amer­i­ca,” a PhRMA spokesper­son told End­points News.

BIO echoed a sim­i­lar sen­ti­ment.

“This dan­ger­ous pro­pos­al has been around for years, but has nev­er been adopt­ed be­cause the risks far out­weigh any po­ten­tial ben­e­fits. Pol­i­cy­mak­ers should re­ject this flawed and worn out idea, and in­stead they should pur­sue re­al re­forms that pro­mote the health and safe­ty of pa­tients and low­er out of pock­et costs for pre­scrip­tion med­i­cines,” a BIO spokesper­son told End­points News.

Low­er­ing drug prices has bi­par­ti­san sup­port, al­though drug man­u­fac­tur­ers and PBMs blame each oth­er for sky­rock­et­ing prices. The Trump ad­min­is­tra­tion has pro­posed var­i­ous steps to curb costs — in­clud­ing peg­ging US prices to over­seas rates — and var­i­ous law­mak­ers have al­so made it a cor­ner­stone is­sue, in­clud­ing Sen­a­tor Chuck Grass­ley, the new chair of the Sen­ate Fi­nance Com­mit­tee, and pres­i­den­tial hope­ful Sen­a­tor Eliz­a­beth War­ren.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.